CA2952223C - Treprostinil formulations - Google Patents

Treprostinil formulations Download PDF

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Publication number
CA2952223C
CA2952223C CA2952223A CA2952223A CA2952223C CA 2952223 C CA2952223 C CA 2952223C CA 2952223 A CA2952223 A CA 2952223A CA 2952223 A CA2952223 A CA 2952223A CA 2952223 C CA2952223 C CA 2952223C
Authority
CA
Canada
Prior art keywords
treprostinil
composition
ion
exchange resin
resin
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
CA2952223A
Other languages
English (en)
French (fr)
Other versions
CA2952223A1 (en
Inventor
Ken Phares
Courtney CHANG
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
United Therapeutics Corp
Original Assignee
United Therapeutics Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by United Therapeutics Corp filed Critical United Therapeutics Corp
Publication of CA2952223A1 publication Critical patent/CA2952223A1/en
Application granted granted Critical
Publication of CA2952223C publication Critical patent/CA2952223C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/192Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/74Synthetic polymeric materials
    • A61K31/785Polymers containing nitrogen
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/58Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. poly[meth]acrylate, polyacrylamide, polystyrene, polyvinylpyrrolidone, polyvinylalcohol or polystyrene sulfonic acid resin
    • A61K47/585Ion exchange resins, e.g. polystyrene sulfonic acid resin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/12Antihypertensives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
CA2952223A 2014-06-13 2015-06-12 Treprostinil formulations Active CA2952223C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201462011689P 2014-06-13 2014-06-13
US62/011,689 2014-06-13
PCT/US2015/035595 WO2015192030A1 (en) 2014-06-13 2015-06-12 Treprostinil formulations

Publications (2)

Publication Number Publication Date
CA2952223A1 CA2952223A1 (en) 2015-12-17
CA2952223C true CA2952223C (en) 2023-08-01

Family

ID=53487449

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2952223A Active CA2952223C (en) 2014-06-13 2015-06-12 Treprostinil formulations

Country Status (9)

Country Link
US (1) US20170095432A1 (ko)
EP (1) EP3164155B1 (ko)
JP (1) JP2017517550A (ko)
KR (1) KR102512890B1 (ko)
CN (1) CN106573066A (ko)
AU (1) AU2015274377B2 (ko)
CA (1) CA2952223C (ko)
ES (1) ES2908142T3 (ko)
WO (1) WO2015192030A1 (ko)

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WO2015061720A2 (en) 2013-10-25 2015-04-30 Insmed Incorporated Prostacyclin compounds, compositions and methods of use thereof
JP6866043B2 (ja) 2014-11-18 2021-04-28 インスメッド インコーポレイテッド トレプロスチニルプロドラッグおよびトレプロスチニル誘導体プロドラッグの製造方法
EP3328361B1 (en) 2015-07-27 2021-09-15 Sun Pharma Advanced Research Company Ltd Drug loaded nanoresin particles
JP6786240B2 (ja) * 2016-03-31 2020-11-18 小林製薬株式会社 粘性経口組成物
WO2020223237A1 (en) 2019-04-29 2020-11-05 Insmed Incorporated Dry powder compositions of treprostinil prodrugs and methods of use thereof
US20210022994A1 (en) * 2019-07-22 2021-01-28 Lupin Holdings, B.V. Sustained release trepostinil-compound microparticle compositions
JP2022546314A (ja) 2019-08-23 2022-11-04 ユナイテッド セラピューティクス コーポレイション トレプロスチニルプロドラッグ
JP2023523557A (ja) 2020-04-17 2023-06-06 ユナイテッド セラピューティクス コーポレイション 間質性肺疾患の治療における使用のためのトレプロスチニル
US11793780B2 (en) 2020-06-09 2023-10-24 United Therapeutics Corporation Prodrugs of treprosiinil
KR20230134480A (ko) 2020-12-14 2023-09-21 유나이티드 쎄러퓨틱스 코포레이션 트레프로스티닐 프로드러그로 질환을 치료하는 방법
CN112704740B (zh) * 2020-12-31 2021-10-29 国药集团致君(深圳)坪山制药有限公司 孟鲁司特树脂复合物及其制备方法和应用
WO2023147443A2 (en) * 2022-01-26 2023-08-03 Tulex Pharmaceuticals Inc. Novel compositions

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Also Published As

Publication number Publication date
EP3164155B1 (en) 2022-02-09
EP3164155A1 (en) 2017-05-10
KR20170016955A (ko) 2017-02-14
WO2015192030A1 (en) 2015-12-17
AU2015274377A1 (en) 2017-01-05
AU2015274377B2 (en) 2020-07-23
KR102512890B1 (ko) 2023-03-21
CA2952223A1 (en) 2015-12-17
US20170095432A1 (en) 2017-04-06
CN106573066A (zh) 2017-04-19
ES2908142T3 (es) 2022-04-27
JP2017517550A (ja) 2017-06-29

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